Insulin Pump Treatment Compared With Multiple Daily Injections for Treatment of Type 2 Diabetes (OpT2mise): A Randomised Open-Label Controlled Trial
What is the safety and efficacy of insulin pump treatment, compared to multiple daily insulin injections (with long-acting and rapid-acting insulin), in patients with type 2 diabetes who have inadequate glycemic control with a basal-bolus regimen after active insulin titration?
OpT2mise was a randomized, parallel-group, multicenter, international, controlled trial. Before randomization, patients underwent a 2-month run-in phase. Following this phase, those patients with a glycated hemoglobin level between 8.0% and 12.0% were randomized to insulin pump treatment or continued therapy with multiple daily insulin injections. Neither patients nor investigators were blinded to treatment. Insulin pumps were configured to deliver half of patients’ total daily dose of insulin as a continuous basal flow; bolus dosing was left to the investigators’ discretion. The primary endpoint was the change in mean glycated hemoglobin from baseline to the end of the randomized phase.
A total of 331 patients entered the study phase and were randomized; 308 patients completed the study. Baseline mean glycated hemoglobin was 9.0% in both groups. At 6 months, mean glycated hemoglobin decreased to 7.9% in the pump treatment group, compared with 8.6% in the multiple daily injection group (difference between groups, -0.7%; 95% confidence interval, -0.9 to -0.04; p < 0.0001). Masked continuous glucose monitoring did not demonstrate significant differences between the two groups for the duration of hypoglycemic events; however, one episode of severe hypoglycemia occurred in the multiple daily injection group (five episodes of hypoglycemia occurred in the pump treatment group, not resulting in hospitalization or ketosis). Pump treatment was not associated with significant weight gain. Those in the pump treatment group did more blood glucose testing compared to those in the multiple injection group during the last 3 months of the study (3.8 vs. 3.1 tests per day).
The investigators concluded that in patients with type 2 diabetes who have inadequate glycemic control with a basal-bolus regimen after active insulin titration, treatment with an insulin pump is better at reducing glycated hemoglobin, compared to multiple daily injections.
This is an important study that corroborates other evidence that insulin pump treatment may be a valuable therapeutic option in appropriately selected diabetic patients who are unable to achieve glycemic control with a basal-bolus regimen after active insulin titration. Future studies should clarify the benefits of continuous subcutaneous insulin infusion (by possibly investigating other clinically meaningful endpoints) and establish the cost-effectiveness of this approach.
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